Hand Gel

Guangzhou Meizi Biotechnology Co. Ltd
Human Otc Drug
NDC 79867-002

Hand Gel is a human otc drug labeled by 'Guangzhou Meizi Biotechnology Co. Ltd'. National Drug Code (NDC) number for Hand Gel is 79867-002. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hand Gel drug includes Alcohol - 70 mL/100mL . The currest status of Hand Gel drug is Active.

Drug Information:

Drug NDC:	79867-002
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Hand Gel
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Hand Gel
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Guangzhou Meizi Biotechnology Co. Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ALCOHOL - 70 mL/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	30 Mar, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part333A
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Guangzhou meizi biotechnology co. LTD
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	581662
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0817505015725 0817505015718 0817505015701
UPC stands for Universal Product Code.
UNII:	3K9958V90M
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
79867-002-01	30 mL in 1 BOTTLE (79867-002-01)	30 Mar, 2020	N/A	No
79867-002-02	30 mL in 1 BOTTLE (79867-002-02)	30 Mar, 2020	N/A	No
79867-002-03	30 mL in 1 BOTTLE (79867-002-03)	30 Mar, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Hand Gel

Gel
Guangzhou meizi biotechnology co. LTD
NDC: 79867-002

Purpose:

Purpose antiseptic

Product Elements:

Hand gel hand gel carbomer homopolymer, unspecified type glycerin water alcohol alcohol trolamine propylene glycol aloe vera leaf

Indications and Usage:

Use hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. recommended for repeated use

Warnings:

Warnings for external use only. flammable. keep away from fire or flame. do not apply around eyes. do not use in ears or mouth. when using this product, avoid contact with eyes. in case of contact, flush eyes with water. stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours. keep out of reach of children. children must be supervised in use of this product.

Do Not Use:

When Using:

When using this product, avoid contact with eyes. in case of contact, flush eyes with water. stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours. keep out of reach of children. children must be supervised in use of this product.

Dosage and Administration:

Directions squeeze as needed into your palms and thoroughly spread on bottom hands. rub into skin until dry.

Stop Use:

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Package Label Principal Display Panel:

Package label - principal display panel 79867-002-03 30ml 79867-002-01 30ml 79867-002-02 30ml

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.